Effectiveness and safety of pulsatile intravenous insulin therapy for the improvement of respiratory quotient in Chinese patients with diabetes mellitus.

Pulsatile intravenous insulin therapy (PIVIT) is a means of imitating naturally occurring insulin pulses artificially. It is thought to improve carbohydrate metabolism, which can be assessed using the respiratory quotient (RQ). The aim of this present study was to assess the efficacy and safety of PIVIT for the improvement of RQ in Chinese patients with diabetes mellitus (DM). This 12-week, multi-center, prospective, randomized, open-label, parallel-group study involved 110 DM patients (both type 1 and type 2) whose RQ was <0.8. Of these, 53 patients formed the control group, in which standard anti-diabetic therapy was maintained, and 54 patients formed the treatment group, which underwent weekly PIVIT in addition to the administration of standard anti-diabetic therapy. RQ was evaluated monthly in control subjects, and before and after every PIVIT treatment in the treatment group. After weekly PIVIT for 12 weeks, the mean RQ increased from 0.70 to 0.90 in the treatment group, but did not change in the control group. The percentage of subjects reporting adverse events (AEs) was 31.5% (17/54) in the treatment group and 9.43% (5/53) in the control group (P=0.0053). The most frequently reported AE (by 12 subjects) was a gastroenteric reaction when these individuals were receiving 50% glucose during the PIVIT treatment. The majority of AEs were mild and did not interfere with the ongoing treatment. Thus, PIVIT can be viewed as tolerated and effective for the improvement of RQ in Chinese DM patients. This study was retrospectively registered with the Chinese Clinical Trial Registry (http://www.chictr.org.cn) on November 13th 2019 (registration no. ChiCTR1900027510).